2 8 6 <1
Rash§ 23 <1 43 <1
Dry skin 11 0 10 0
Vascular Disorders
Hypertension¶ 39 16 8 3
Investigations
Weight decreased 31 2 12 0
Nervous System Disorders
Dysgeusia 24 0 9 0
Headache 11 <1 12 <
Dizziness 11 0 7 0
Endocrine Disorders
Hypothyroidism 21 0 <1 <1
Respiratory, Thoracic, and Mediastinal Disorders
Dysphonia 20 <1 4 0
Dyspnea 19 3 29 4
Cough 18 <1 33 <1
Blood and Lymphatic Disorders
Anemia 17 5 38 16
Musculoskeletal and Connective Tissue Disorders
Pain in extremity 14 1 8 <1
Muscle spasms 13 0 5 0
Arthralgia 11 <1 14 1
Renal and Urinary Disorders
Proteinuria 12 2 9 <1
Other clinically important adverse reactions (all grades) that were reported in <10% of patients treated with CABOMETYX included: wound complications (2%), convulsion (<1%), pancreatitis (<1%), osteonecrosis of the jaw (<1%), and hepatitis cholestatic (<1%).
Table 2. Laboratory Abnormalities Occurring in ≥ 25% Patients Who Received CABOMETYX
Test CABOMETYX
(n=331) Everolimus
(n=322)
All
Grades Grade 3-4 All
Grades Grade 3-4
Chemistry
AST increased 74 3 40 <1
ALT increased 68 3 32 <1
Creatinine increased 58 <1 71 0
Triglycerides increased 53 4 73 13
Hypophosphatemia 48 8 36 5
Hyperglycemia 37 2 59 8
Hypoalbuminemia 36 2 28 <1
ALP increased 35 2 29 1
&nbs |
